[Federal Register Volume 84, Number 182 (Thursday, September 19, 2019)]
[Notices]
[Pages 49308-49309]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20312]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0008]


Citizen Petitions and Petitions for Stay of Action Subject to the 
Federal Food, Drug, and Cosmetic Act; Guidance for Industry; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance for industry entitled ``Citizen 
Petitions and Petitions for Stay of Action Subject to Section 505(q) of 
the Federal Food, Drug, and Cosmetic Act.'' Among other things, this 
guidance provides FDA's current thinking on what constitutes a 505(q) 
petition and describes some of the considerations that FDA will take 
into account in determining whether a petition is submitted with the 
primary purpose of delaying the approval of an application. This 
guidance finalizes the draft guidance for industry entitled ``Citizen 
Petitions and Petitions for Stay of Action Subject to Section 505(q) of 
the Federal Food, Drug, and Cosmetic Act'' issued in October 2018.

DATES: The announcement of the guidance is published in the Federal 
Register on September 19, 2019.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2009-D-0008 for ``Citizen Petitions and Petitions for Stay of 
Action Subject to Section 505(q) of the Federal Food, Drug, and 
Cosmetic Act.'' Received comments will be placed in the docket and, 
except for those submitted as ``Confidential Submissions,'' publicly 
viewable at https://www.regulations.gov or at the Dockets Management 
Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential

[[Page 49309]]

information that you do not wish to be made publicly available, submit 
your comments only as a written/paper submission. You should submit two 
copies total. One copy will include the information you claim to be 
confidential with a heading or cover note that states ``THIS DOCUMENT 
CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, 
including the claimed confidential information, in its consideration of 
comments. The second copy, which will have the claimed confidential 
information redacted/blacked out, will be available for public viewing 
and posted on https://www.regulations.gov. Submit both copies to the 
Dockets Management Staff. If you do not wish your name and contact 
information to be made publicly available, you can provide this 
information on the cover sheet and not in the body of your comments and 
you must identify this information as ``confidential.'' Any information 
marked as ``confidential'' will not be disclosed except in accordance 
with 21 CFR 10.20 and other applicable disclosure law. For more 
information about FDA's posting of comments to public dockets, see 80 
FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the 
Division of Drug Information, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale 
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Kim Thomas, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6282, Silver Spring, MD 20993-0002, 301-796-3601.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Citizen Petitions and Petitions for Stay of Action Subject 
to Section 505(q) of the Federal Food, Drug, and Cosmetic Act.'' This 
guidance provides information regarding FDA's current thinking on 
interpreting section 505(q) of the Federal Food, Drug, and Cosmetic Act 
(FD&C Act) (21 U.S.C. 355(q)). Section 505(q) of the FD&C Act governs 
certain citizen petitions and petitions for stay of Agency action that 
request that FDA take any form of action related to a pending 
application submitted under (1) section 505(b)(2) of the FD&C Act 
(referred to in this document as a 505(b)(2) application), (2) section 
505(j) of the FD&C Act (referred to in this document as an abbreviated 
new drug application (ANDA)), or (3) section 351(k) of the Public 
Health Service Act (PHS Act) (42 U.S.C. 262(k)) (referred to in this 
document as a 351(k) application).
    This guidance describes FDA's interpretation of section 505(q) of 
the FD&C Act regarding how the Agency determines (1) if the provisions 
of section 505(q) addressing the treatment of citizen petitions and 
petitions for stay of Agency action (collectively, petitions) apply to 
a particular petition and (2) if a petition would delay approval of a 
pending ANDA, 505(b)(2) application, or 351(k) application. This 
guidance also describes how FDA interprets the provisions of section 
505(q) requiring that (1) a petition include a certification and (2) 
supplemental information or comments on a petition include a 
verification. It also addresses the relationship between the review of 
petitions and pending ANDAs, 505(b)(2) applications, and 351(k) 
applications for which the Agency has not yet made a decision on 
approvability. In addition, this guidance describes some of the 
considerations that FDA will take into account in determining whether a 
petition is submitted with the primary purpose of delaying the approval 
of an application under section 505(q)(1)(E) of the FD&C Act.
    This guidance supersedes the guidance for industry entitled 
``Citizen Petitions and Petitions for Stay of Action Subject to Section 
505(q) of the Federal Food, Drug, and Cosmetic Act,'' issued in 
November 2014, and finalizes the draft guidance announced in the 
Federal Register of October 3, 2018 (83 FR 49935). In that Federal 
Register notice, FDA gave interested parties an opportunity to submit 
comments by December 3, 2018, to ensure that FDA considers the comments 
before beginning work on the final version of the guidance. FDA 
received a number of comments on the draft guidance. FDA has considered 
the comments and made clarifying revisions to the draft guidance.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Citizen Petitions and Petitions for Stay 
of Action Subject to Section 505(q) of the Federal Food, Drug, and 
Cosmetic Act.'' It does not establish any rights for any person and is 
not binding on FDA or the public. You can use an alternative approach 
if it satisfies the requirements of the applicable statutes and 
regulations. This guidance is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR 10.20, 10.30, and 10.35 have been 
approved under OMB control number 0910-0191; the collections of 
information in 21 CFR 10.31 have been approved under OMB control number 
0910-0679; and the collections of information in 21 CFR 314.54, 314.94, 
and 314.102 have been approved under OMB control number 0910-0001.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or 
https://www.regulations.gov.

    Dated: September 13, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-20312 Filed 9-18-19; 8:45 am]
BILLING CODE 4164-01-P